Duns Number:480610476
Device Description: Dental implant motor system, SET
Catalog Number
-
Brand Name
MD 30
Version/Model Number
2004IDI
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K042434
Product Code
DZI
Product Code Name
Drill, Bone, Powered
Public Device Record Key
f890507c-603c-4735-8d67-57920015b6b6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 13, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 72 |
2 | A medical device with a moderate to high risk that requires special controls. | 95 |